跳至主要内容
临床试验/EUCTR2004-004384-29-GB
EUCTR2004-004384-29-GB进行中(未招募)1 期

Double blind randomised controlled trial of Levosimendan versus Dopexamine in septic shock

Dr GED DEMPSEY, University Hospital Aintree0 个研究点目标入组 20 人开始时间: 2005年2月15日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

入选标准

  • 1). Presence of septic shock (as given by)
  • Septic shock is characterised by:
  • ·Hypotension:
  • Mean arterial pressure <60mmHg or the requirement for inotropic or vasopressor drugs to maintain a pressure above this, despite adequate volume resuscitation.
  • ·Perfusion abnormalities:
  • Lactic acidosis, oliguria and mental impairment associated with sepsis.
  • ·Systemic Inflammatory Response Syndrome (SIRS) as a result of a known or presumed bacteraemia.
  • SIRS is defined as two or more of following:
  • i).Hypothermia (<36C) or hyperthermia (>38C).
  • ii).Heart rate >90 bpm.
  • iii).Respiratory rate >20 bpm
  • iv).Leucopenia (<4000/mm3) or leucocytosis (>12,000/mm3).
  • 2). When the use of Dopexamine added to the inotropic regimen may be considered to be beneficial. This will be due to the presence of one or more of the following.
  • i).Renal dysfunction / oliguria. (Urine output of <0.5 ml/Kg/hr for 2 consecutive hours, in adequately resuscitated patients).
  • ii).Lactic acidosis.(pH<7.35 with lactate>2mmol/l).
  • iii).Increasing intramucosal gastric acidosis. ( Decreased pHi ).
  • Such that an agent considered to preserve splanchnic perfusion may be deemed necessary.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • ·Age < 18 years of age
  • ·Involvement in another randomised controlled trial within 3 months.
  • ·Child bearing potential.
  • ·Know hypertrophic obstructive cardiomyopathy
  • ·Known stenotic valvular pathology
  • ·Patient not expected to survive more than 24 hrs.

研究者

发起方
Dr GED DEMPSEY, University Hospital Aintree

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